Drug · Small Molecule
Metformin
CI-DRUG-00000376Explore in graph →NCIt C61612 CHEMBL1431 CIViC Approved
Regulatory
Approvals (3)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
openfdaProvenance
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | RIOMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. RIOMET is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (1) | approved | Oct 20, 2008 | openfda |
| US FDA | — | Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) | approved | Jun 3, 2005 | openfda |
| US FDA | — | RIOMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. RIOMET is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (1) | approved | Sep 11, 2003 | openfda |
Data updated 2 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 56 | 28 | 52 | 365 | 3 | US | Sep 11, 2003 | Jul 31, 1996 |
| Malignant Prostate Neoplasm | Phase4 | Phase 4 | 4 | 1 | 3 | 28 | 0 | — | — | Jul 8, 2005 |
| Malignant Bladder Neoplasm | Phase4 | Phase 4 | 1 | 1 | 0 | 3 | 0 | — | — | 2015-10 |
| Malignant Breast Neoplasm | Phase3 | Phase 3 | 6 | 3 | 4 | 36 | 0 |
Curated evidence
Clinical evidence (5)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 27325049
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| SDHB Mutation1 | ||||||||
| Metformin + Vandetanib | ||||||||
Clinical trials
Trials with this intervention (372)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT05237960 | Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia | active not recruiting | Phase 2 | 34 | University of ArizonaOTHER | 2 | Sep 28, 2026 | clinicaltrials |
| NCT02365597 | An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer | active not recruiting | Phase 2 |